Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

February 12, 2014 updated by: Gynecologic Oncology Group

A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols.
  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49008
        • CCOP - Kalamazoo
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Women's Cancer Center - Las Vegas
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ University Hospital
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Stony Brook, New York, United States, 11794-8174
        • Stony Brook University Cancer Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Hope A Women's Cancer Center
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates - Midtown Tulsa
    • Oregon
      • Salem, Oregon, United States, 97301
        • Williamette Gynecologic Oncology PC
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
    • Tennessee
      • Knoxville, Tennessee, United States, 37901
        • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Houston, Texas, United States, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • Massey Cancer Center at Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer

    • Recurrent or persistent disease

  • Measurable disease

    • At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
    • Tumors within a previously irradiated field are considered non-target lesions

  • Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease

    • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel

  • Platinum-resistant or refractory disease

    • Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN*
  • AST and ALT ≤ 3 times ULN* NOTE: * ≤ 5 times ULN if due to hepatic metastases

Renal

  • Creatinine clearance ≥ 45 mL/min

Other

  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No neuropathy (sensory or motor) > grade 1
  • No active infection requiring antibiotics
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following:

    • Monoclonal antibodies
    • Cytokines
    • Small-molecule inhibitors of signal transduction
  • At least 3 weeks since prior biologic or immunologic therapy
  • At least 24 hours since prior growth factors
  • No concurrent routine colony-stimulating factors

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
  • No prior pemetrexed disodium

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to > 25% of bone marrow
  • At least 2 weeks since prior radiotherapy and recovered

Surgery

  • Recovered from prior surgery

Other

  • No prior cancer treatment that would preclude study participation

  • No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration

    • Concurrent low-dose (≤ 325 mg/day) aspirin allowed
  • At least 3 weeks since other prior therapy for the malignant tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Antitumor activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)
Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 8, 2004

First Submitted That Met QC Criteria

July 9, 2004

First Posted (Estimate)

July 12, 2004

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0126Q
  • LILLY-H3E-US-JMGP
  • CDR0000372919

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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